Catalog Number

23641

Brand Name

Welch Allyn, Inc.

Version/Model Number

901033

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2019

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K861516

Product Code

ETY

Product Code Name

TESTER, AUDITORY IMPEDANCE

Public Device Record Key

45c8f03d-cc71-4f81-b575-5485b70a8339

Public Version Date

October 01, 2019

Public Version Number

6

DI Record Publish Date

September 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-